Drug recall
Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid…
FDA recall event 83791 · Class II · Randox Laboratories Ltd.
Key facts
| Event ID | 83791 |
|---|---|
| Recall numbers | Z-0282-2020, Z-0283-2020 |
| Recalling firm | Randox Laboratories Ltd. |
| Product type | Devices |
| Products | Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid Protein Calibrators are intended for in vitro diagnostic use in the calibration of ASO…, Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273205039 Product Usage: The Randox Rheumatoid Factor Latex-Enhanced Immunorutbidimetric Test Kit is an in vitro diagnostic… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British standard from NIBSC. Ref = 64/002. The calibrator values have been adjusted to re-align to… |
| Initiation date | Aug 9, 2019 |
| Report date | Nov 13, 2019 |
| Termination date | Jan 8, 2021 |
| City | Crumlin (North) |
| Country | Ireland |
| FEI number | 2965 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: